A Safety and Efficacy Study of DRM02 in Subjects With Plaque Psoriasis

NCT ID: NCT01993433

Last Updated: 2021-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-03-31

Brief Summary

The purpose of this study is to determine whether DRM02 is safe and effective in the treatment of plaque psoriasis when applied twice daily for 6 weeks.

Detailed Description

This is a double-blind, randomized, within-subject control, study enrolling 20 subjects with plaque psoriasis and designed to assess the safety, tolerability, and preliminary efficacy of DRM02.

Safety will be assessed during the study, through adverse events, local skin responses, urinalysis, serum chemistry and hematology laboratory testing, physical examination and vital signs.

Preliminary efficacy will be assessed through the Physician's Lesion Assessment (PLA) and the Severity of Psoriasis Area Severity Index (PASI) from only the two plaques identified at the baseline visit.

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

DRM02

DRM02 Topical Gel, 0.25%

Group Type: EXPERIMENTAL

DRM02

Intervention Type: DRUG

Vehicle

DRM02 Topical Gel, Vehicle

Group Type: PLACEBO_COMPARATOR

Vehicle

Intervention Type: OTHER

Interventions

DRM02

Intervention Type: DRUG

Vehicle

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Male or female 18 to 70 years of age.
• Plaque-type psoriasis with two lesions of similar size and have an identical score of at least 6 but no more than 8 on the sum of the individual components of the Severity of Psoriasis Area Severity Index (PASI) at the Target Lesion scale.
• Male or non-pregnant, non-lactating females.
• Signed informed consent.

Exclusion Criteria

• Subjects who have extensive, and/or 'inverse', and/or exfoliative psoriasis.
• Subjects who have taken any systemic treatment for psoriasis within the 4 weeks prior to baseline.
• Prior or concomitant use of topical treatments for psoriasis to within 10 cm of the target lesion within the 4 weeks prior to baseline.
• Use of Enbrel within the 4 weeks prior to baseline.
• Psoralen & ultraviolet A therapy (PUVA) or the use of ultraviolet B (UVB) therapy and/or excessive or prolonged exposure to ultraviolet light within the 4 weeks prior to baseline.
• Use of Humira or Remicade within the 3 months prior to baseline.
• Use of Stelara within the 6 months prior to baseline.
• Subjects who have taken oral retinoids for psoriasis within the 6 months prior to baseline.
• Subjects who have poor skin condition within 5 cm of the target lesion.
• Subjects who are current drug or alcohol abusers; have a history of immunodeficiency disease or are a poor medical risk because of other systemic diseases or active uncontrolled infections.
• Subjects with an unstable medical condition or a medical condition not adequately controlled with standard medical therapy.
• Subjects who are actively participating in an experimental therapy study or who have received experimental therapy within 30 days
• Subjects who have a clinically significant laboratory value at screening.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dermira, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Beth Zib

Role: STUDY_DIRECTOR

Dermira, Inc.

Locations

Clinique Médicale Dr Isabelle Delorme

Drummondville, Quebec, Canada

Innovaderm Research, Inc

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

DRM02-PSO02

Identifier Type: -

Identifier Source: org_study_id